Versatile orthopedic device

ABSTRACT

A versatile orthopedic device is arranged to convert between ligament and osteoarthritis treatment, and to accommodate a variety of leg anatomies. The orthopedic device is preferably configured as a double-upright brace indicating struts, frame component sections and associated hinges preferably intended to be along both medial and lateral sides of a wearer&#39;s leg. A strap kit with an unloading strap system may be added to the orthopedic device for conversion into an orthopedic device for osteoarthritis relief.

FIELD OF THE DISCLOSURE

The disclosure relates to a versatile orthopedic device, and morespecifically to a knee brace arranged in a streamline and efficientmanner for a ligament user, and configured to be converted to a kneebrace for osteoarthritis treatment.

BACKGROUND

Typically, orthopedic devices include a frame that comprises at leastone support member. When there are multiple support members, the devicemay include rotational hinges that assist and control movement of thelimb. Suitable straps may maintain the brace on the limb, and otherfeatures such as pads may relieve pressure of the brace on the limb andsurrounding areas.

A predominant orthopedic device is a knee brace. Knee braces are used tostabilize the knee by preventing excessive movement of the knee, or tofacilitate movement of the knee. Many braces comprise a frame and havehinges on at least one of the lateral and medial sides of the kneejoint. Straps are used to secure the brace to the leg or knee. Aninjured knee can be fit with an “off the shelf” brace or a “custom-fit”brace, with the selection of the brace depending on the size and shapeof an individual's leg.

Many knee braces reduce knee instability following an injury, fatigue orto treat impairment of the knee, particularly if the knee has damagedligaments. Braces may be recommended for walking, skiing, running,twisting, pivoting, or jumping activities. Besides providing increasedstability to the knee, braces may also decrease the risk of injuring theknee or leg, or provide corrective assistance to the knee.

To maximize its supportive, protective and comfort aspects, it isdesirable that a knee brace securely and precisely fit the leg of thewearer. While custom-fit braces are made to closely conform to the exactgeometry of a leg of a wearer, it is common for the geometry of the legto change over time requiring even a custom-fit to accommodate a varietyof geometries of the leg. As for off-the-shelf braces, these braces mustbe configurable to accommodate a variety of leg geometries irrespectiveof the particular geometry of a leg.

In recognizing the need for effective knee braces, various knee braceshave been introduced to the marketplace. Such knee braces, however, havecomprised relatively heavy, bulky apparatuses that fail to provideventilation and evenly distribute pressure from the brace on the leg ofthe wearer. Many contemporary braces are deficient because the braces donot consistently provide or lack adjustment features for forming a firm,comfortable and secure interface between the leg and knee of the wearerand the brace. Because of these drawbacks, many knee braces detract fromthe user's endeavor.

The features of the embodiments described are provided in recognition ofthe need for orthopedic braces and components for use therewith that areadjustable in both custom-fit and off-the-shelf braces to achievesuperior functional performance characteristics while being comfortableto the wearer when worn. This recognition is realized with theembodiments described.

Knee braces are widely used to treat a variety of knee infirmities. Suchbraces may be configured to impart forces or leverage on the limbssurrounding the knee joint to relieve compressive forces within aportion of the knee joint, or to reduce the load on that portion of theknee. If knee ligaments are weak and infirm, a knee brace may stabilize,protect, support, unload, and/or rehabilitate the knee.

The knee is acknowledged as one of the weakest joints in the body, andserves as the articulating joint between the thigh and calf musclegroups. The knee is held together primarily by small but powerfulligaments. Knee instability arising out of cartilage damage, ligamentstrain and other causes is relatively commonplace since the knee jointis subjected to significant loads during the course of almost anyphysical activity requiring using the legs.

A healthy knee has an even distribution of pressure in both the medialand lateral compartments of the knee. It is normal for a person with ahealthy knee to place a varus moment on the knee when standing so thepressure between the medial and lateral compartments is uneven but stillnatural.

One type of knee infirmity that many individuals are prone to having iscompartmental osteoarthritis. Compartmental osteoarthritis may arisewhen there is a persistent uneven distribution of pressure in one of themedial and lateral compartments of the knee. Compartmentalosteoarthritis can be caused by injury, obesity, misalignment of theknee, or due to aging of the knee.

A major problem resulting from osteoarthritis of the knee is that thesmooth cartilage lining the inside of the knee wears away. This leads toa narrowing of the joint space with developing cysts and erosions in thebone ends. Because of the narrowing of the joint, bone comes directly incontact with bone, and an uneven distribution of pressure developsacross the knee which may cause the formation of bone spurs around thejoint; all ultimately lead to increasing pain and stiffness of thejoint.

While there are no cures to osteoarthritis, there are many treatments.Individuals who have a diagnosis of isolated medial or lateralcompartmental osteoarthritis of the knee are confronted with a varietyof treatment options such as medications, surgery, and nonsurgicalinterventions. Nonsurgical interventions include using canes, lateralshoe wedges, and knee bracing.

Knee bracing is useful to provide compartmental pain relief by reducingthe load on the affected compartment through applying an opposingexternal valgus or varus moment about the knee joint. Unloading kneebraces have been shown to significantly reduce osteoarthritis knee painwhile improving knee function.

While known knee braces succeed at reducing pain or at stabilizing aknee joint, many users find these braces to be bulky, difficult to don,complicated to configure, and uncomfortable to wear. Embodiments of thedisclosure have streamlined features capable of providing relief formedial or lateral compartmental osteoarthritis, or functional stabilityof the knee while providing a configuration that has a low profile andunexpectedly provides a more conforming and supportive fit for theorthopedic device.

SUMMARY

Various embodiments described are directed to a versatile orthopedicdevice arranged to convert between ligament and osteoarthritistreatment, and to accommodate a variety of leg anatomies. According tothe embodiments, the orthopedic device is configured as a double-uprightbrace indicating struts, frame component sections and associated hingespreferably intended to be along both medial and lateral sides of awearer's leg.

The embodiments are arranged to be cold-formed by a clinician to conformto the individual anatomy of the wearer. Frame components are formedfrom a metal, such as an aluminum alloy, that will permit “cold-forming”while maintaining sufficient integrity to withstand forces exerted bythe wearer. Cold-forming implies that the frame components do notrequire heating for reshaping, but rather can be bent by suitable meansto cater to individual anatomies while retaining sufficient structuralintegrity while being worn by a user without yielding to various forcesexerted by the wearer.

Different frame components and other elements may be formed frommaterials exhibiting different strengths and other properties enablingthe clinician to custom form the device according to specific needs of awearer. Either or both medial and lateral sides may be reinforced withstruts having strength greater than a frame component to increasemedial-lateral stability.

The ability to cold-form the frame allows the device to be sold as anoff-the-shelf product without the need for fabricating each individualdevice for an individual anatomy. The device is versatile in the mannerof accommodating a variety of anatomies and indications, and may becustom-made as well.

Embodiments may include slots formed on struts that allow a clinician toresize the length of the device to permit short, standard or longversions of the device, and potentially reduce hinge binding onosteoarthritis patients.

In addition to resizing and modifying the shape of the frame components,the device includes means for additionally accommodating anatomy of theleg. The device may include a tibia pad adapted to conform to part ofthe shape of the second frame component and be adjustable in locationalong the second frame component to correspond to the tibia of anindividual wearer of the brace. As the medial side of the anterioraspect has a generally flat profile corresponding to the tibia andperiosteum, and the lateral side has a rounded profile corresponding tothe lateral muscle compartment, the second frame component can becontoured due to its malleability to the lower leg. It may be difficultto obtain an accurate match for an individual user along the secondcomponent, and the tibia pad can fill the void of the medial side of thesecond component between the leg and orthopedic device without requiringguesswork of shaping the second frame component itself.

The embodiments preferably have a streamlined and short profile to allowa wearer freedom of movement and reduce weight of the device. Theembodiments may enable a short brace ranging from a distance from anouter peripheral edge of the first frame component to an outerperipheral edge of the second frame component when the orthopedic deviceis in full extension and is about or less than 45 cm. A combinedthickness of the first extension and the first strut defining an uprightis about or less than 10 millimeters. A thickness of the first framecomponent extending about a leg may be about or less than 5 millimeters.

A strap kit and method for installing the orthopedic device includes anosteoarthritis strap kit arranged for securing to a basic frame of theorthopedic device by a subshell system. The subshell system, which maybe configured as more flexible than the basic frame, is adapted toevenly distribute pressure about a user's anatomy.

The orthopedic device is preferably modular in design to treat a varietyof indications, including ACL (anterior-collateral ligament), MCL(medial-collateral ligament), LCL (lateral-collateral ligament) andposterior-collateral ligament (PCL), rotary and combined instabilities;mild to severe ligament laxity, sprain or deficiency; protection andstabilization of ligaments after surgical repair or reconstruction;medial or lateral compartment unloading for unicompartmentalosteoarthritis or articular cartilage healing; post-operativerehabilitation and functional support plus unloading protocols requiringmedial or lateral joint loads during recovery; functional support withor without varus/valgus alignment; and contact and impact activities.

BRIEF DESCRIPTION OF THE DRAWINGS

The orthopedic device is described regarding the accompanying drawingswhich show preferred embodiments according to the device described. Thedevice as disclosed in the accompanying drawings is illustrated forexample only. The elements and combinations of elements described belowand illustrated in the drawings can be arranged and organizeddifferently to result in embodiments still within the spirit and scopeof the device described.

FIG. 1 is a perspective view of an embodiment of an orthopedic device.

FIG. 2A is a front elevational view of a first frame component in anupper frame assembly of FIG. 1 in a non-contoured configuration.

FIG. 2B is a front elevational view of a strut for the upper frame.

FIG. 3A is a perspective view of a first frame assembly in theembodiment of FIG. 1.

FIG. 3B is a schematic view of adjustment of the first frame assembly inthe embodiment of FIG. 1.

FIG. 4A is a front elevational view of a second frame component for anembodiment of the orthopedic device in a non-contoured configuration.

FIG. 4B is a front elevational view of a variation of the second framecomponent in FIG. 4A in a non-contoured configuration.

FIG. 4C is a side elevational view of the second frame component in FIG.4C.

FIG. 5A is a side elevational view of a hinge assembly embodiment.

FIG. 5B is a rear schematic portion view of the hinge assembly of FIG.5A.

FIG. 5C is a front schematic portion view of the hinge assembly of FIG.5A without various hinge components.

FIG. 5D is a perspective schematic view of a hinge assembly in FIG. 1and including the first frame assembly of FIG. 2A and the second framecomponent of FIG. 4B.

FIG. 6A is a plan view of a first subshell for use with the first framecomponent of FIG. 2A.

FIG. 6B is an elevational view of the first subshell of FIG. 6A.

FIG. 7 is a plan view of a second subshell for use with the second framecomponent of FIG. 4B.

FIG. 8A is a perspective view of modification of the first frameassembly of FIG. 2A with an osteoarthritis strap kit.

FIG. 8B is a perspective view of modification of the second frameassembly of FIG. 4B with an osteoarthritis strap kit.

FIGS. 8C-8F are perspective views showing modification of the orthopedicdevice of FIG. 1 with an osteoarthritis strap kit.

FIG. 9 is a schematic view showing a cross-section of a lower leg.

FIG. 10 is a schematic frontal view of adjustment of the tibia pad ofFIG. 9 relative to the second frame component of FIG. 4A.

FIG. 11 is a schematic top view showing the tibia pad relative to thesecond frame component and a liner.

FIG. 12A is a perspective view of a tibia pad for use in the orthopedicdevice.

FIG. 12B is an elevational view of the tibia pad of FIG. 9.

FIG. 13 is an elevational view of a tibia strap pad of the orthopedicdevice.

DETAILED DESCRIPTION OF VARIOUS EMBODIMENTS A. Overview

A better understanding of different embodiments of the disclosure may behad from the following description read with the accompanying drawingsin which like reference characters refer to like elements.

While the disclosure is susceptible to various modifications andalternative constructions, certain illustrative embodiments are shown inthe drawings and are described below. It should be understood, however,there is no intention to limit the disclosure to the embodimentsdisclosed, but on the contrary, the intention is to cover allmodifications, alternative constructions, combinations, and equivalentsfalling within the spirit and scope of the disclosure.

It will be understood that, unless a term is defined in this disclosureto possess a described meaning, there is no intent to limit the meaningof such term, either expressly or indirectly, beyond its plain orordinary meaning

Any element in a claim that does not explicitly state “means for”performing a specified function, or “step for” performing a function, isnot to be interpreted as a “means” or “step” clause as specified in 35U.S.C. section 112.

B. Definitions

For ease of understanding the disclosed embodiments of an orthopedicdevice, the anterior and posterior portions of the orthopedic device aredescribed independently. The anterior and posterior portions of theorthopedic device function together to support and stabilize anatomicalportions of the wearer of the device.

For further ease of understanding the embodiments of an orthopedicdevice as disclosed, a description of a few terms is necessary. As used,the term “proximal” has its ordinary meaning and refers to a locationnext to or near the point of attachment or origin or a central point, orlocated toward the center of the body. Likewise, the term “distal” hasits ordinary meaning and refers to a location situated away from thepoint of attachment or origin or a central point, or located away fromthe center of the body. The term “posterior” also has its ordinarymeaning and refers to a location behind or to the rear of anotherlocation. The term “anterior” has its ordinary meaning and refers to alocation ahead of or to the front of another location.

The terms “rigid,” “flexible,” “compliant,” and “resilient” maydistinguish characteristics of portions of certain features of theorthopedic device. The term “rigid” should denote that an element of thedevice is devoid of flexibility. Within the context of frame or supportmembers or shells that are “rigid,” it should indicate that they do notlose their overall shape when force is applied, and they may break ifbent with sufficient force. The term “flexible” should denote thatfeatures are capable of repeated bending such that the features may bebent into retained shapes or the features retain no general shape, butcontinuously deform when force is applied.

The term “compliant” is used to qualify such flexible features asconforming to the shape of another object when placed in contacttherewith, via any suitable natural or applied forces, such asgravitational forces, or forces applied by external mechanisms strapmechanisms. The term “resilient” is used to qualify such flexiblefeatures as returning to an initial general shape without permanentdeformation. As for the term “semi-rigid,” this term is used to connoteproperties of support members or shells that provide support and arefree-standing; however, such support members or shells may have somedegree of flexibility or resiliency.

C. Various Embodiments of the Orthopedic Device and Components for UseTherewith

According to an embodiment of the disclosure illustrated in FIG. 1, aversatile orthopedic device 10 includes a basic frame including a firstframe component 12 defining first and second extensions 24, 26 and acenter section 28 spanning between the first and second extensions 24,26 and having a center line 30; a second frame component 14 definingfirst and second extensions 36, 38 and a center section 40 spanningbetween the first and second extensions 36, 38; and a hinge assembly 400including first and second hinges or joints 20, 22 connecting the firstand second frame components 12, 14 by first and second struts.

The second frame component 14 may define a flattened region 32preferably located between the center section 40 and one of the first orsecond extensions 36, 38. The opposing side preferably does not includesuch flattened region. This flattened region is a solution for solvingthe problem of the anatomy of the medial side of the lower leg inrelation to the discussion on FIG. 9, and as discussed in connectionwith another solution discussed in connection with FIGS. 10-13. Ratherthan including an insert, as in FIGS. 10-13, the lower frame component14 is permanently deformed to the medial side of the lower leg.

The hinges may be selected from a variety of hinges found in orthopedicdevices. An exemplary hinge is described in U.S. Pat. App. Pub.2012/0059296, published Mar. 8, 2012, or U.S. Pat. 7,597,675, grantedOct, 6, 2009, and incorporated in its entirety by reference.

The basic frame forms a “double upright” brace or “cage-style” deviceadapted as a knee brace. While the exemplary embodiment shows the firstframe component in a proximal location along an anterior side and asecond frame component in a distal location also along an anterior side,the basic frame is not limited to this configuration. The first framecomponent can be arranged along an anterior side, while the second framecomponent can be arranged along a posterior side to form a “step throughdesign.” Both the first and second frame components may be arrangedalong the posterior side.

Suitable padding may be provided along the frame portions of theorthopedic device. The padding may be constructed in a variety of types,and a preferable padding is edge bound and thermoformed. The paddingpreferably extends beyond the periphery of the frame components tominimize discomfort and assure the wearer's anatomy is sufficientlyprotected. An exemplary padding may be found in U.S. Pat. No. 8,585,623,granted Nov. 19, 2013 or U.S. Prov. App. No. 62/103,678, filed Jan. 15,2015, incorporated herein by reference.

In a variation, the orthopedic device 10 has first and second struts 16,17 securing to and overlapping the first and second extensions 24, 26 ofthe first frame component 12 and securing to the first and second hinges20, 22. In a variation, the orthopedic device 10 also includes first andsecond struts 18, 19 securing to and overlapping the first and secondextensions 36, 38 of the second frame component 14. The overlap 25 maybe the entirely or substantially along the length of the extension ofthe first and second frame components. As it is desired to maintain astreamlined configuration, a combined thickness of the extensions andthe first struts may be about or less than 10 millimeters.

Various removable fasteners 76, 78, such as Chicago screws, are used tosecure the struts to the frame components. Any of the struts 16, 17, 18,19 may include an adjustment system, such as slots (as shown as 37 inFIG. 1 or in FIG. 5A) to enable lengthening or shortening the orthopedicdevice along length 23. A distance 23 from an outer peripheral edge 27of the first frame component 12 to an outer peripheral edge 29 of thesecond frame component 14 when the orthopedic device is in fullextension (knee is in 0 degrees of flexion) is about or less than 45 cm.

The adjustment system may, in part, allow for correction of legcurvature by forming a lateral inward or outward angle of the upperframe in relation to the lower frame, as discussed in U.S. Pat. No.6,875,187, granted on Apr. 5, 2005, in relation to the securableslidable engager described, and U.S. Pat. App. Pub. No. 2013/0144197,published Jun. 6, 2013, incorporated herein by reference.

In an exemplary embodiment, the first strut 16 defines an elongate slotat a first end (generally in the proximal direction), and the fasteners76, 78 extend through openings defined by the first frame component andthe slot. When the fasteners are loosened, the first strut is slidablerelative to the first frame component and secured to the first framecomponent without movement by regulation of the first fastener.

The first and second frame components are preferably constructed fromaluminum and may be malleable from a cold forming treatment to allow foreasy customization of the frame elements to a particular leg shape.Other exemplary materials that may be used for constructing the frameinclude metals such as titanium, and steel, thermoset resin compositesystems including glass or carbon fibers, and thermoplastics renderedrigid by way of material composition and geometry of the frame members.The first and second frame components may be formed from differentmaterials or materials having different properties such as strength andrigidity and are not limited to be formed from the same materials.

The struts are preferably constructed from a malleable material such asan aluminum alloy. The struts may be constructed from an aluminum alloystronger than an aluminum alloy forming the first frame component. Theframe components may be constructed from aluminum alloys 5052 or 6061,and the struts may be formed from the same alloys or stronger alloys.The clinician can select which types of struts to use on the basis ofthe needs of a wearer such that the orthopedic device may be furnishedas a strap kit with a selection of different struts available for theclinician to use. The struts are not limited to being selected from thesame material but each strut or pairs of struts may have a materialdifferent from another depending on the indications of an individualwearer.

Even if the frame components and the struts are formed from the same orsubstantially same materials, the struts may be extended along an innersurface of the extensions and reinforce the frame components. Thisarrangement provides flexibility in tailoring the rigidity of thelateral and medial sides of the orthopedic device, and eliminatespermanently fixing the rigidity of sides of the orthopedic device inthat the struts may be removed and switched as desired.

Suitable straps 46, 58, 60, 74 may depend from the first and secondframe components 12, 14. D-rings or suitable means 62 may be pivotallysecured by fasteners 64 to the frame components. A tibial strap 46 mayextend between the first and second extensions 36, 38, and include acover or sleeve to cover any strap ends or other items forming part ofor protruding from the strap 46 to provide a streamlined appearance.

In the embodiment of FIG. 1, an osteoarthritis strap kit 48 secures tothe basic frame. In a variation shown in FIG. 2A, the strap 48 includesa hook element 54 securable to a keyhole 56 formed along the centersection 28 at a first side of the first frame component 12 and spiralsthe first side of second frame component 14 while crossing over to thesecond side generally proximate the second hinge 22.

A flexible subshell 66 may secure to first frame component 12. Theflexible subshell is secured to the first frame component 12, and has afirst end extending laterally beyond the first side portion to flexrelative to a side portion of the first frame component. The subshellmay have a contoured edge extending beyond the peripheral contour toflex relative to the frame peripheral contour. The subshell may bemounted along an interior surface of the first frame component. Thestrap 58 may secure to or over the subshell 66 to evenly distributepressure over the wearer's anatomy.

The subshell 66 may selectively attach to the first frame component 12and has protrusions extending through slots formed by the first framecomponent 12 to prevent pivoting of the subshell 66 relative to thefirst frame component. The fastener 64 for the D-ring 62 may extendthrough the subshell 66 to prevent it from slipping away from the firstframe component. Subshells may be attached at any portion of the firstand second frame components and the method described above is merelyexemplary.

The osteoarthritis strap kit transforms the orthopedic device into anunloading type knee brace, under the principles described in U.S. Pat.No. 7,198,610, granted Apr. 3, 2007, and U.S. Pat. No. 5,277,698 grantedJan. 11, 1994, both incorporated in their entirety by reference. Thestrap may be a strap tightener assembly for a strap assembly for anorthopedic device discussed in U.S. Pat. App. Pub. No. 2013/0184628,published Jul. 18, 2013, and incorporated in its entirety by reference.

FIGS. 2A-4B depict alternative embodiments of the first and second framecomponents 111, 114, respectively, in a flat condition prior tocontouring, unlike in FIG. 1, and hence are in a non-contouredconfiguration, or in a contoured configuration, as noted. The first andsecond frame components 111, 114 are arranged similarly as thecomponents in FIG. 1. It will be noted in the following examples thatthe first frame component 111 embraces both the first or upper frame,and the struts for each side of the first frame. For simplicity, asingle strut is described by such strut may be oriented or adapted forboth sides of the first frame 112.

Referring to FIG. 2A, the first or upper frame 112 of the first framecomponent 111 defines first and second extensions 124, 126 and a centersection 128 spanning between the first and second extensions 124, 126and having a center line 130. The center line 130 defines a location ofthe center section 128 having a shorter height 142 than areas outside ofthe center line 130. The shorter height 142 facilitates bending of thecenter portion 128 by a clinician to customize the contour of the centersection 128 to an individual wearer.

The center section 128 forms a dip or slight gradual swoop 152 towardthe center line 130 from corners 132, 134 defined at the junction offirst and second sides of the center section 128 and the first andsecond extensions 124, 126, respectively. The dip 152 providescontouring to the anatomy of the wearer and enables a pleasing aestheticappearance.

The first and second extensions 124, 126, which are along thelongitudinal length of a leg, are oriented at an angle less than 90degrees in the pre-contouring condition to better approximate theanatomy of the wearer. As the orthopedic device is streamlined andminimal in size, the length of the first and second extensions 124, 126are preferably short, as denoted by length 154. The length 154 (takenfrom inner corners 150) of the extensions 124, 126 may be shorter than alength 153 of the center section 128 from the inner corners 150 to thecenter line 130. If desired to lengthen the orthopedic device,regulation of the position of the struts (as discussed in relation toFIG. 1) may be had by adjusting the slot of the struts relative topositioning holes 144 on the extensions 124, 126 for receivingfasteners.

The first frame 112 defines first and second wing sections 132, 134opposite the corners 150 and extending in an opposite direction to thecenter section 128. The wing sections 132, 134 provide extra materialand area to the first frame 112 to accommodate various attachments suchas D-rings for supporting straps and subshells. The wing sections 132,134 extend from the inner corners 150 to outer corners 146, and haveapertures 148 for securing D-rings, slots 170 for easing bending forcontouring the first frame component 111, ventilating the framecomponent, and coupling to a subshell.

Turning to FIG. 2B, the strut 116 (which may comprise the shape ofeither strut 16 or strut 17 in the embodiment of FIG. 1) includes afirst end 121 contoured to fall within the width of the first and secondextensions 124, 126, and a second end 123 having a gear profile 125 forforming part of a hinge, as shown in FIG. 5D. The second end 123 alsodefines an extension stop 119 for limiting extending of the hinge, andan opening 122 for forming part of the hinge, as discussed in moredetail in relation to FIG. 5D.

An elongate slot 118 extends downwardly from the first end 121 towardthe second end 123. The elongate slot 118 is adapted to receivefasteners, as shown in FIGS. 3A and 3B, and permit sliding movement ofthe strut 116 relative to the extensions and affixation thereof at adesired location along the extensions. Indicia 119 are provided alongthe length of the slot 118 to enable a clinician understanding ofrelative lengths of both struts, as in the embodiment of FIG. 1.

Referring to FIG. 3A, a coupling part 129 is located on a first or innerside of the strut 116, and the extensions of the first frame 112, suchthat the strut 116 located between the coupling part 129 and acorresponding one of the extensions. The coupling part 129 defines aD-ring portion 131 having a slot 133 for receiving a strap. The D-ringportion 131 extends toward and/or beyond the periphery of the firstframe component 112 and flexibly therefrom for receiving a strap. Bothlateral and medial, or first and second sides of the first framecomponent 112 include coupling parts 129, and a strap extendstherebetween.

While a D-ring may be formed from the strut 116 material itself and beintegrated therewith, the coupling part 129 is advantageous in that itcan be adjusted in height according to the location of the strutrelative to the extensions. This enables a floating adjustment of theD-ring and corresponding strap according to the height of the firstframe component as a whole.

The coupling part 129 defines a head portion 137 that has a width lessthan a width of the strut but greater than the slot 118. The headportion 137 defines a recessed portion 139 that may have an elongateconfiguration oriented generally parallel to the slot 118. The recessedportion 139 further defines at least one aperture 141 for receiving atleast one fastener 143, 145 that is arranged to extend through thecoupling part 129, slot 118 and the extension. The recessed portion 139is arranged to minimize projection of the at least one fastener 143, 145into or against the user of the orthopedic device. One end of the atleast one fastener is retained or abuts the coupling part 129 within therecessed portion 139 and another end of the at least one fastenerengages an outer side of the extension.

The coupling part 129 is preferably formed from a single andcontinuously monolithic piece to maintain stabilization as both supportwith the head portion 137 for the at least one fastener and heightadjustment of the first frame component 111, and for maintaining thestrap between opposed sides (i.e., medial and lateral) of the firstframe component even when the height of the first frame component isadjusted in height. A hinge or thinned portion 135 from the materialforming the coupling part is located between the D-ring portion 132 andthe head portion 137 for permitting some laxity or adjustability of thecoupling part when tensioning a strap carried by coupling parts. TheD-ring and the head portions 133, 137 may be substantially rigid,particularly the head portion 137 for securely receiving the at leastone fastener, whereas the hinge portion 135 is flexible at least in partdue to its thinned profile.

FIG. 3B shows that the at least one fastener 143, 145 is loosened by atool T from the outer side of the extension for height adjustment of thefirst frame component 111. The at least one fastener is preferablyretained between the coupling part 129, the struts 116 and theextensions 124, 126. A clinician can adjust the height when the at leastone fastener 143, 145 is loosened, and tighten at a desired setting byreferring to the indicia on the strut.

As illustrated in FIG. 4A, an embodiment of the second frame component114 defines first and second extensions 136, 138 and a center section140 spanning between the first and second extensions 136, 138. Thesecond frame component 114 may have positioning holes 156 for receivingfasteners securing to struts (not shown), slots 158 for securing tosubshells, and apertures 160 for securing D-rings. The second framecomponent 114 may be configured to include struts, as in FIG. 2B,adjusting the height of the second frame component, and may be similarlyarranged as with the struts for the upper frame component.

Alternatively, the center section 128 may have a uniform height, asshown in the second component 114 by way of uniform height 162 along thecenter section 140. The center section 140 of the second frame component114, however, may likewise have similar features as the center section128 of the first frame component such as the variable height and dip.

FIG. 4B shows a variation of the second component 314. The secondcomponent 314 includes first and second extensions 336, 338 and a centersection 340 spanning therebetween. Unlike in the embodiment of FIG. 4A,the first and second extensions 336, 338 are substantially upright,generally forming a right angle relative to the center section, and donot exhibit the angled or acute angle arrangement of FIG. 4A.

A fillet 342 exists between each of the first extension 336 and thecenter section 340, and the second extension 338 and the center section340, to provide a wider transition between the sections. As in the firstcomponent, the center section 340 tapers in height 364 toward a centerpoint 366 of the center section 340 relative to the extension of thefirst and second extensions 336, 338. In addition, the width 362 of thecenter section 340 tapers toward the center point 366 to reduce theweight of the center section and minimize extension of the centersection along the leg, as it is desirable the orthopedic possesses astreamlined footprint over the leg of a wearer. The first component maylikewise have its center portion adapted similarly to the secondcomponent of FIG. 4B.

To minimize the features added to the frame component, either of theframe components can have slots for receiving various straps. In theexample of FIG. 4B, the second frame component 314 has slots 346, 347adapted for receiving a tibia strap, as shown in FIG. 1. The secondcomponent 314 defines slots 358 for securing to subshells, and apertures360 for securing D-rings.

FIGS. 4B and 4C depict the second frame component 314 as having anindent 344, preferably formed on the medial side of the orthopedicdevice. The indent 344 is adapted for conforming to the anatomy of theleg on the medial side as this configuration tracks the naturalcurvature of a medial leg.

The second frame component 314 may include end portions 348 at the firstand second extensions 336, 338, that are adapted to directly engage thehinge assembly and forms part of the hinge in a polycentric hingearrangement as evidenced by the gear profile. The end portions 348 mayinclude apertures 340 through which a pin of a hinge engage. The endportions 348 can be modified to receive hinge covers 406, 408, as usedin the hinge assembly 400 of FIG. 5C, such that the hinge covers 406,408 are adapted for engagement.

In the illustrated embodiment, the end portions 348 include a gearprofile 349, and an extension stop 350, as in the upper frame 112. Suchconfiguration is preferably used in the hinge variation of FIG. 5D.

FIGS. 5A and 5B illustrate a hinge assembly 400 that may be used in theorthopedic device, and enables securing of the first and second framecomponents 112, 114 at various locations. The hinge assembly 400 ispreferably provided on both sides of the orthopedic device.

The hinge assembly 400 includes first and second struts 402, 404 havingfirst and second end hinge covers 406, 408, respectively. The first andsecond struts 402, 404 are secured to one another by an outer plate 410and an inner plate 412, connecting via hinge fasteners or pins 424, 426,428 and 430. A rotation stop 20, having a variety of geometriesdepending on the desired rotation, is insertable between the first andsecond hinge covers 406, 408. A condyle plate 416 may secure to theinner side of the hinge assembly 400, and a suitable pad may be securedto the condyle pad. The hinge components described above may functionsimilarly to the hinge described in U.S. Pat. App. Publ. No.2012/0059296, published on Mar. 8, 2012, and incorporated by reference.

The struts 402, 404 preferably form protrusions 419, 421 forming strapslots 420, 422. In the depicted embodiment, the protrusions extend fromopposing sides of the hinge assembly 400 to receive the posterior upperleg strap 74 in FIG. 2, and the anterior lower leg or tibial strap 46,in FIG. 1. The upper leg strap 74 and the lower leg strap 46 counteractwith one another to retain, at least in part, the orthopedic device onthe leg of the wearer. The protrusions 419, 421 preferably are arrangedto extend sufficiently beyond the first and second frame components sothe frame components do not interfere with the straps regardless as tothe height position the first and second frame components secure to thehinge assembly, and specifically the first and second struts 402, 404.The protrusions 419, 421 eliminate the need for additional features,such as b-rings, to be assembled to the hinge assembly.

The first strut 402 shows how the hinge assembly 400 may be adjustablysecured to the first component. The first strut 402 includes a slot 418permitting height adjustment of the first component relative to thestrut assembly 400 such that the fasteners 76, 78 may be adjustablysecured and tightened at a preferred height for an individual user ofthe orthopedic device. The strut assemblies at both the lateral andmedial sides of the orthopedic device may include the slot 418 foruniform, symmetric height adjustment or asymmetric height adjustmentdepending on the user's leg anatomy and length. The second strut 404 maylikewise include a slot similar to the slot 418 for height adjustment ofthe second frame component relative to the hinge assembly.

In the event the orthopedic device is converted for use as anosteoarthritis brace, the fasteners 76, 78 may be loosened yet stillengaging the hinge assembly and the first frame component so that theyare slidable and securable against each other, as taught in U.S. Pat.No. 6,875,187. The motion enable and variable angular relationship canbe modified to treat inward or outward leg curvature through correctionof the knee joint orientation. Alternatively, the fasteners may besecured to maintain an angular mismatch relative to the hinge assemblyon an opposite side of the leg.

FIG. 5D illustrates a hinge assembly 450 in combination with the firstframe component of FIG. 3A and the lower frame component of FIG. 4B. Thehinge assembly 450 is beneficial in that it employs the frame componentsthemselves and reduces parts for orthopedic device as a whole. The gearprofiles 125, 349 of the first and second frame components,respectively, engage one another and are biased or enabled for rotationby rivets 472, 474 extending through the openings 122, 340,respectively. The rivets 472, 474 may be received by bearing rings 462,464 located within the openings 122, 340, and arranged for facilitatingrotation of the first and second frame components. Plates 454, 468 mayserve as bearings or washers for stabilizing movement of the first andsecond frame components relative to the hinge assembly and inner andouter covers 452, 470 provide anchoring for the rivets 472, 474. Anextension or flexion stop 456 may be securable to the hinge assembly 450and by being engaged to the plates 454, 468 by a fastener 453. Theextension or flexion stops can be arranged as in U.S. Pat. App. Pub. No.2012/0059296.

FIG. 6A shows an exemplary embodiment of a subshell 166 that may beattached to the first frame 111 of FIG. 3, and be used to support afirst end of a strap tightener assembly to eliminate the need for anykey-hole or similar provisions in the frame components. The periphery orprofile 192 of the subshell, at least at a rearward side, should extendbeyond the corresponding frame component with the strap tightenerassembly, particularly for an upper leg.

The subshell defines a plurality of slots 168 at a rear end tofacilitate bending of the subshell and ventilate the subshell over thewearer's anatomy as the subshells are preferably intended to spread overa greater area of a wearer's anatomy to evenly distribute pressure. Thesubshell 166 defines an aperture 182 for receiving a fastener (asdiscussed regarding FIG. 2) to assure the subshell secures to the framecomponent. The subshell 166 likewise may define a key-hole 184 having alarger portion 186 for receiving a hook element (as in FIG. 1) of thestrap tightener assembly, and a smaller portion 188 for locking the hookelement with the subshell 166. A reinforcing edge 190 may be providedabout the smaller portion 188 to reinforce the subshell 166 whereat thestrap tightener assembly may pull at its greatest.

Referring to FIG. 6B, the subshell 166 may include locking elements 172for engaging the through-extending slots 170 defined by a correspondingframe component. The locking elements 172 may include protruding necks194 with a head portion 196 adapted to snap through and connect to thematerial of the frame component about the through-extending slot. Whileshown as being elongate, the locking elements may be formed from avariety of shapes.

FIG. 7 depicts a second subshell 200 for attachment to the second framecomponent 114 of FIG. 4, and has a periphery or profile 210 adapted toanatomy of a lower leg. The second subshell 200 includes a key-hole 206similar to the first subshell, and slots 202, locking elements 204, andan aperture 208.

A method of converting an orthopedic device from a ligament brace to anosteoarthritis brace in any of the aforementioned embodiments mayinclude securing first and second subshells to a first side of the firstcomponent and the second component; attaching a first end of a strap tothe first subshell, spiraling the strap across a second side of thefirst component opposite the first component and extending the strap tothe second subshell; and attaching a second end of the strap to thesecond subshell.

FIGS. 8A and 8B exemplify how the first and second subshells 166, 200couple to the first and second frame components 111, 114 for couplingthe osteoarthritis strap kit 48 to the orthopedic device 10 in FIG. 1.The strap kit 48 may have a hook element 54 that engages a keyhole 184of the first subshell 166.

Referring to FIG. 8A, the locking elements 172 engage the first frame112 by the through-extending slots 170. A fastener assembly may bearranged for securing the subshell 166 to the first frame 112, as taughtin U.S. Pat. App. Pub. 2013/0331751, published on Dec. 12, 2013. Thefastener assembly includes a first cap 171 that extends through theaperture 148 to engage a second cap 173 arranged for receiving a post ormale portion of the first cap 171 by a female portion of the second cap173. A fastener 169 secures the first and second caps 171, 173 to oneanother, and retains the subshell 166 to the first frame 112.

The subshell 166 is mountable to either of first or second sides of thefirst frame 112. A D-ring assembly 167 may be located on an opposed sideof the first frame 112 where the subshell 166 is not located, whereasthe subshell 166 includes a slot 191 for receiving a strap which mayspan between the subshell and the D-ring assembly. The area of thesubshell having the slot 191 preferably extends beyond the first frameand the area may have some flexibility to permit better tensioning ofthe strap against a leg of a user. Coupling parts including D-ringportions 127, 129 may likewise be located below the subshell and or beformed by the aforementioned coupling parts in FIGS. 3A and 3B.

The subshell 200 is similarly arranged as the subshell 166 and withlocking elements 204 engaging or being retained by slots 358. Acorresponding D-ring assembly 181 may operate with the subshell 200 tosupport a strap. D-ring assemblies 177, 179 may be located above thesubshell for securing a supplementary strap. A buckle assembly 189, astaught in U.S. Pat. No. 7,198,610 may form part of the strap kit 48, andengage a keyhole 206 of the subshell 200.

FIGS. 8C-8F exemplify how the strap kit 48 may be arranged to treatmedial or lateral compartmental osteoarthritis in the orthopedic device10. In FIGS. 8C and 8D, the strap kit 48 is arranged to exert unloadingon a first side of the orthopedic device, whereas FIGS. 8E and 8F exertunloading on a second side of the orthopedic device, when the orthopedicdevice is worn by a user.

Referring to FIGS. 9-12, the orthopedic device may include a tibial pad230 adapted to accommodate a user's lower leg, and permit universalityof the orthopedic device. The tibia pad 230 may fill in a void definedbetween the second frame component 114 on a side of the brace, such asthe medial side for reasons discussed below due to the anatomy of alower leg.

FIG. 9 shows a cross-section of a lower leg and how the anterior aspectof the lower leg defines an apex. The medial side of the anterior aspecthas a generally flat profile corresponding to the tibia and periosteum,whereas the lateral side has a rounded profile corresponding to thelateral muscle compartment. The orthopedic device is generallysymmetrical between the lateral and medial sides to allow for universalsizing for left and right legs, and particularly the first and secondframe components. Whereas the upper leg or thigh is generallysymmetrical among left and right legs, the lower leg is not, asevidenced by FIG. 9. The second frame component can be contoured due toits malleability to the lower leg, and it may be difficult to obtain anaccurate match for an individual user. With the tibia pad 230, the shapeof the second frame component 114 can be maintained without requiringguesswork of shaping the second frame component 114 itself.

FIG. 10 shows how the tibia pad 230 can be moved to either side of thecenter section 140 of the second frame component 114, particularly ineither corner 141, 143 of the center section 140. The contours of thecorners 141, 143 are symmetrical with one another, and the contour ofthe profile 240 permits adjustment of the tibia pad 230 at a variety ofportions at each corner 141, 143 for adjustment to a user's individualanatomy, and for either left or right leg use. As shown in FIG. 10, thetibia pad is preferably sized and configured to fit within the width 162of the center section 140.

FIG. 11 illustrates the tibia pad 230 against the inner surface 246 ofthe second frame component 114, and with the profile 240 adapted to theshape of the center section 140. A liner 244 may be placed against thetibia pad 230 and the inner surface 246 of the second frame component114. The liner 244 is pliable and conforms to the shape of the secondframe component 114 and the tibia pad 230. The liner 244 may comprisefoam and enables a generally uniform surface against the user's leg.

FIG. 12A shows an embodiment of the tibia pad 230 adapted for both rightand left legs, and is adapted in combination with the lower framecomponent, as shown in FIGS. 10 and 11. The tibial pad 230 includes asubstantially flat first surface 232 bounded by first and second ends236, 238 of the tibia pad 230. A profile 242 of the first surface 232 isgenerally adapted to a contour of the tibia of a user. The tibia pad 230has a rounded second surface 234 having a profile 240 generallycorresponding to the inner contour of the center section 140 of thesecond frame component 114.

FIGS. 12A and 12B show the tibia pad 230 as being preferably symmetricin shape from the first and second ends 236, 238 so as to accommodateeither direction the tibia pad 230 is placed along the second framecomponent. As shown in the contoured configurations of the orthopedicdevice, the center section of the second frame component has a curvatureas it extends between the first and second sections corresponding tolateral and medial sides of the orthopedic device and leg of the user.The tibia pad is configured and dimensioned to fit at a plurality oflocations along the curvature of the second frame component.

The first surface 232 extends from a base portion 248 which assures asubstantially flat surface from which the second surface 234 rises. Torelieve any stress points and minimize discomfort, the tibia pad 230includes tapering ends 252 which meet the first and second ends 236, 238and merges with the base portion 248 in a graduated manner, and filletedside haunches 250. The tapering ends 252 and filleted side haunches 250ease donning of the brace, and prevent interference with any clothing,skin and hair along the leg.

The tibia pad 230 may be formed from a variety of padding materials. Thetibia pad may be formed from ethylene vinyl acetate (EVA) type foam cutto shape, and having compressible properties, yet having sufficientrigidity. The rigidity supports against the leg and accommodates thevoid created by the generally uniform profile of the second framecomponent on the medial side of the orthopedic device against the tibia,for either left or right sided applications.

The tibia pad 230 may be secured to the frame component permanently ortemporarily, or alternatively may be secured to the liner. The tibia padmay include hook material, and the frame component or the liner mayinclude a loop material to which the hook material secures.Alternatively, the tibia pad may adhere to the frame component with anadhesive or other known fastener means.

FIG. 13 depicts a strap pad 209 arranged along the tibia strap 207 inFIG. 8. The tibia strap 209 in FIG. 8 should extend between the hingeassemblies and can be adjustably lengthened according to desiredtension, and the strap pad 209 is preferably dimensioned and configuredto fit within a distance between hinge assemblies on lateral and medialsides of the orthopedic device.

A first surface 254 of the strap pad 209 is substantially flat andshould face the leg of the wearer. A second surface 256 of the strap pad209 is spaced from the first surface 254, and a curved profile 262extends from between the first and second surfaces 254, 256, and firstand second ends 258, 260 to provide a gentle taper of the strap pad 209and improve cushioning. The strap pad 209 may be removably mounted totibia strap 207 depending on the level of cushioning desired by theuser.

It is to be understood that not necessarily all objects or advantagesmay be achieved under any embodiment of the disclosure. Those skilled inthe art will recognize that the orthopedic device may be embodied orcarried out in a manner that achieves or optimizes one advantage orgroup of advantages as taught without achieving other objects oradvantages as taught or suggested.

The skilled artisan will recognize the interchangeability of variousdisclosed features. Besides the variations described, other knownequivalents for each feature can be mixed and matched by one of ordinaryskill in this art to construct an orthopedic device under principles ofthe present disclosure. It will be understood by the skilled artisanthat the features described may be adapted to other types of orthopedicdevices. Hence this disclosure and the embodiments and variationsthereof are not limited to knee braces, but can be utilized in anyorthopedic devices.

Although this disclosure describes certain exemplary embodiments andexamples of an orthopedic device, it therefore will be understood bythose skilled in the art that the present disclosure extends beyond thespecifically disclosed knee brace embodiments to other alternativeembodiments and/or uses of the disclosure and obvious modifications andequivalents thereof. It is intended that the present disclosure shouldnot be limited by the particular disclosed embodiments described above,and may be extended to orthopedic devices and supports, and otherapplications that may employ the features described.

1. A versatile orthopedic device, comprising: a first frame componentdefining first and second sides having first and second extensions,respectively, and a center section spanning between the first and secondextensions; a second frame component; a first hinge connecting the firstand second frame components, the first and second frame componentsforming part of the first hinge; wherein the first frame component isadjustable in height along both first and second sides between the firsthinge and the center section.
 2. The versatile orthopedic device ofclaim 1, further comprising a first strut securing to and overlappingthe first extension of the first frame component and securing to thefirst hinge.
 3. The versatile orthopedic device of claim 2, wherein thefirst strut and the first frame component are each constructed from ametal.
 4. The versatile orthopedic device of claim 2, wherein the firststrut is constructed from an aluminum alloy stronger than an aluminumalloy forming the first frame component.
 5. The versatile orthopedicdevice of claim 2, wherein the first strut extends substantially thelength of the first extension of the first frame component.
 6. Theversatile orthopedic device of claim 2, wherein the first strut isconfigured and dimensioned to be stronger than the first extension ofthe first frame component, the first strut having a width no greaterthan a width of the first extension.
 7. The versatile orthopedic deviceof claim 2, wherein the first strut defines an elongate slot located ata first end, the orthopedic device further comprising a first couplingpart arranged to receive a first fastener adapted to extend through thefirst strut and first extension and tighten against the first couplingpart and the first extension with the first strut therebetween, thefirst strut slidable relative to the first frame component and arrangedto secure to the first frame component without movement by regulation ofthe first fastener.
 8. The versatile orthopedic device of claim 7, thefirst coupling part defines a D-ring section adapted for receiving astrap and a mounting section through which the first fastener extends.9. The versatile orthopedic device of claim 8, wherein the firstcoupling part defines a living hinge between the D-ring section and themounting section.
 10. The versatile orthopedic device of claim 2,wherein the first strut defines an elongate slot for adjusting a heightof the first frame component, the first strut including height sizeindicia along the elongate slot.
 11. The versatile orthopedic device ofclaim 8, wherein the first frame component defines first and secondwings located between the first and second extensions and the centersection, respectively, the first and second wings having a greater widththan the first and second extensions and the center section.
 12. Theversatile orthopedic device of claim 11, wherein the first and secondwings define through-extending slots arranged obliquely relative to thefirst and second extensions.
 13. The versatile orthopedic device ofclaim 11, wherein the first wing section defines a plurality ofthrough-extending slots arranged obliquely relative to the firstextension, the orthopedic device further comprising a first subshellhaving a first protrusion configured to fit within at least one of thethrough-extending slots and secure therewith.
 14. The versatileorthopedic device of claim 2, wherein the first strut is longer than thefirst extension.
 15. The versatile orthopedic device of claim 1, whereinthe center section defines a shorter height at a middle length than atareas proximate the first and second extensions.
 16. A versatileorthopedic device, comprising: a first frame component defining firstand second extensions and a center section spanning between the firstand second extensions; a first strut securing to and overlapping thefirst extension of the first frame component, the first strut definingan elongate slot located at a first end; a first coupling part arrangedto receive a first fastener adapted to extend through the first strutand first extension and tighten against the first coupling part and thefirst extension with the first strut therebetween, the first strutslidable relative to the first frame component and arranged to secure tothe first frame component without movement by regulation of the firstfastener.
 17. The versatile orthopedic device of claim 16, the firstcoupling part defines a D-ring section adapted for receiving a strap anda mounting section through which the first fastener extends.
 18. Theversatile orthopedic device of claim 17, wherein the first coupling partdefines a living hinge between the D-ring section and the mountingsection.
 19. The versatile orthopedic device of claim 16, wherein thefirst strut defines an elongate slot for adjusting height of the firstframe component, the first strut including height size indicia along theelongate slot.
 20. A versatile orthopedic device, comprising: a firstframe component defining first and second extensions and a centersection spanning between the first and second extensions; first andsecond struts securing to and overlapping the first and secondextensions, respectively, of the first frame component, the first andsecond struts defining an elongate slot located at a first end; firstand second fasteners securing the first and second struts to the firstand second frame components; a second frame component having first andsecond extensions and a center section spanning between the first andsecond extensions; first and second hinges connecting the first andsecond frame components, respectively, a second end of the first andsecond struts forming part of the first and second hinges.